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Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer

T

Tanta University

Status

Completed

Conditions

Caesarean Section
Double Layer
Single Layer
Uterine Scar
Transvaginal Ultrasound

Treatments

Procedure: Double-layer closure
Procedure: Single-layer closure

Study type

Interventional

Funder types

Other

Identifiers

NCT07074522
36264MS426/11/23

Details and patient eligibility

About

This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.

Full description

Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.

Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.

Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.

Enrollment

60 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 20 to 40 years old.
  • Pregnant women underwent their first cesarean section.

Exclusion criteria

  • Body mass index (BMI) ≥ 30 kg /m2.
  • Multiple gestations.
  • Uterine malformation.
  • Placenta previa.
  • Placenta accreta.
  • Uterine or cervical fibroid.
  • Any previous uterine operation or any medical disease that compromises wound healing, such as diabetes mellitus, collagen diseases, anemia, or corticosteroid therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Single layer group
Experimental group
Description:
Patients who underwent single-layer closure of the transverse lower segment during cesarean section.
Treatment:
Procedure: Single-layer closure
Double layer group
Experimental group
Description:
Patients who underwent double-layer closure of the transverse lower segment during cesarean section.
Treatment:
Procedure: Double-layer closure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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